MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for IMPELLA CP manufactured by Abiomed Europe Gmbh.
[176774995]
Impella cp placed for cardiogenic shock, purge solution line leak went undetected; no alarms came on, air embolism occurred, echo showed bubbles in the lv likely originating from the device; air embolism, severe hemolysis, acute renal failure and severe hypoxemia, lactic acidosis and pump malfunction ensued resulting in rapid death. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092537 |
| MDR Report Key | 9636482 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-19 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2020-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-27 |